With the hoped-for media splash accomplished, 181 CEOs, including from Bayer, BMS, J&J and Pfizer, published an updated “Statement on the Purpose of a Corporation.” They’ve committed to benefit “customers, employees, suppliers, communities and shareholders.” What’s it all about really?
Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.
The Medical Device Single Audit Program (MDSAP) has worked out its kinks and is poised for exponential growth, but it may be a while before the initiative makes headway in the EU and China.
Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.
Have you ever put off doing something you knew needed to be done, even though you had the ability and money for it? Think exercising, getting a will or going to the dentist (hopefully you have dealt with at least the latter). In the same way, many study sponsors put off aggregating and utilizing key intelligence on their previously used investigator sites for use in future strategic site selections. At times, there will be unique reasons for engaging with a certain investigator site or the need to use research-naive sites. However, if previously used sites will be considered for a new study, it is vital to review some key information for a truly strategic site selection process. Let's take a look at some of these key, yet often forgotten, areas.
Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.
Virtual pharmaceutical/biotech companies often receive conflicting advice regarding the need to establish an internal cGMP quality system. Either they’re told “you need an extensive set of cGMP SOPs” or “you don’t need any cGMP SOPs at all.” Which advice is correct?
Approximately 75,000 procedures were completed in 2018 using cerclage cables and trochanteric grips, devices used in the repair of broken or surgically altered bones. This procedure volume is increasing every year.
During the American College of Cardiology annual meeting in March, researchers from Stanford University, Apple Inc., and other academic centers unveiled the Apple Heart Study, a first-of-its-kind large-scale study involving more than 400,000 members of the general population (iPhone and Apple Watch owners). The goal of the study was to identify users with a potentially lethal irregular heart rhythm called atrial fibrillation (AF).
Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.
How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.
Are we dangerously reliant on outsourcing to China, and is this outsourcing without the good of U.S. patients in mind? Our drug development and manufacturing outsourcing industry can’t escape the ins-and-outs of geopolitical and global affairs. Learn more in this free collection of articles